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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02240 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| COG-AAML10B18 | Other Identifier | Children's Oncology Group | |
| CDR0000675724 | Other Identifier | Clinical Trials.gov |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research study is studying lestaurtinib with or with chemotherapy in samples from young patients with leukemia. Studying the effects of lestaurtinib with or without chemotherapy in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of this treatment on cancer cells. It may also help doctors identify biomarkers related to cancer.
PRIMARY OBJECTIVES:
I. Determine the potential of lestaurtinib with or without chemotherapy agents in treating samples from infants with leukemia.
II. Determine whether FLT3 protein expression level and/or activation and sensitivity to lestaurtinib differ between subgroups of infants with leukemia.
III. Determine whether lestaurtinib activates STAT5, AKT, and RAS-MAPK and other pathways.
IV. Determine whether lestaurtinib can synergize with other chemotherapy agents kill infant leukemia cells.
OUTLINE: This is a multicenter study.
Cryopreserved specimens are studied in vitro with lestaurtinib with or without chemotherapy agents. Samples are analyzed for FLT3 protein expression and/or activation; sensitivity to lestaurtinib with or without chemotherapy agents; and activation of STAT, AKT, and RAS-MAPK and other pathways by western blot. The most effective treatment from this study is then validated in vivo in a NOD/SCID xenograft model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Cryopreserved specimens are studied in vitro with lestaurtinib with or without chemotherapy agents. Samples are analyzed for FLT3 protein expression and/or activation; sensitivity to lestaurtinib with or without chemotherapy agents; and activation of STAT, AKT, and RAS-MAPK and other pathways by western blot. The most effective treatment from this study is then validated in vivo in a NOD/SCID xenograft model. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | Samples are analyzed in laboratory studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Expression level and activation state of FLT3 protein, determined by Western blotting and FACS | Up to 4 months | |
| TKI sensitivity, determined by MTT and annexin V assays | Up to 4 months | |
| Baseline activation and inhibition of STAT5, AKT, and RAS-MAPK and other pathways, examined with Western blotting and phosphospecific antibodies | Baseline | |
| Incidence of cell death in primary infant leukemia samples treated with sequenced combinations of chemotherapy and FLT3 TKI using MTT and annexin V binding assays and median effect analysis | Up to 4 months |
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Inclusion Criteria:
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Samples from infants with leukemia
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Brown, MD | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Oncology Group | Monrovia | California | 91006-3776 | United States |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |